UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036423 |
|---|---|
| Receipt number | R000041502 |
| Scientific Title | semi-experimental study |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/04/06 10:05:41 |
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Basic information
Public title
The Development of the Intravenous Drip Management System by the ICT Utilization
Acronym
The Development of the Intravenous Drip Management System by the ICT Utilization
Scientific Title
semi-experimental study
Scientific Title:Acronym
semi-experimental study
Region
| Japan |
Condition
Condition
Patients receiving fluid therapy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The development and evaluation of intravenous drip management system by the ICT utilization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of intravenous drip doses per one hour by the presence or absence of system utilization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Nurses manages of intravenous drip with the system mobile.
Interventions/Control_2
Nurses manages of intravenous drip without the system mobile.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients that circulation status and respiratory status are stable, and the patients who got permission of the chief physician.
Key exclusion criteria
The patients that circulation status and respiratory status are unstable, and the disturbed patient by delirium and dementia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chiahru |
| Middle name | |
| Last name | Matsumoto |
Organization
Kumamoto University
Division name
Department of Nursing, Faculty of Life Sciences
Zip code
862-0976
Address
4-24-1, Kuhonji, Chuo-ku, Kumamoto, Kumamoto 862-0976, Japan
TEL
096-373-5517
matsu-c@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiahru |
| Middle name | |
| Last name | Matsumoto |
Organization
Kumamoto University
Division name
Department of Nursing, Faculty of Life Sciences
Zip code
862-0976
Address
4-24-1, Kuhonji, Chuo-ku, Kumamoto, Kumamoto 862-0976, Japan
TEL
096-373-5517
Homepage URL
matsu-c@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Sanritz Autmation Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, kumamoto 860-8556, Japan
Tel
096-373-5966
byi-senshin@jimu.kumamoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 05 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041502
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
